Life Science Update | May 2026
AI Risks With the Patent Office: What Life Science Companies Should Be Asking Now Robert J. Hilton, Ph.D. & Justin Culbertson, Ph.D. AI tools are reshaping patent preparation and prosecution,...
Federal Circuit Confirms Patent Eligibility of Gene Therapy Patent in Regenexbio Inc. v. Sarepta Therapeutics
Key Takeaway: Genetically engineered cultured host cells containing recombinant nucleic acids useful for gene therapy are patent-eligible for being markedly different from anything occurring in nature. In REGENXBIO Inc. v....
Life Science Update | August 2025
Eyeing the Prize of the U.S. Patent System, the Trump Administration Proposes Patent Maintenance Fee Overhaul Jane Dai, Ph.D. & Susan M. Janicki, Ph.D. The Trump administration is considering changing the U.S....
FDA Announces Review of New Clinical Trials That Export Americans’ Biological Samples to Hostile Countries
On June 18, 2025, the U.S. Food and Drug Administration (FDA) announced that it will review new clinical trials that involve sending biological samples to “hostile countries,” to prevent exploitation...
Two Bills Introduced to Target “Patent Thickets” and “Product Hopping”
On March 17, 2025, a bipartisan group of senators introduced two bills intended to decrease the cost of prescription drugs. The sponsors include Chuck Grassley (R-Iowa), John Cornyn (R-Texas), Richard...
Novo Nordisk Seeks to Block Compounded Versions of Diabetes / Weight Loss Drug
On October 22, 2024, Novo Nordisk made a submission to the U.S. Food and Drug Administration (FDA) nominating Novo Nordisk’s semaglutide products (WEGOVY, OZEMPIC and RYBELUS) to be included in...
Science Group Sues FDA Over New Laboratory-Developed Test Rule
On August 19, 2024, the Association for Molecular Pathology (AMP) sued the FDA to challenge a new rule that allows the FDA to regulate laboratory developed tests (LDTs). The rule, which became effective on July 5, 2024, explicitly categorizes in vitro LDTs intended for clinical use as medical devices, placing such LDTs within the purview of the FDA. The complaint was filed in the Southern District of Texas. AMP’s suit follows another suit filed by a trade association, the American Clinical Laboratory Association, targeting the same rule.
WIPO Member States Adopt New Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge
On May 24, 2024, member states of the World Intellectual Property Organization (WIPO) adopted a new treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge that was over 20 years in the making. Genetic resources, which can include medicinal plants, agriculture crops and animal breeds, cannot themselves be claimed as intellectual property. However, inventions developed using genetic resources can be protected, usually through patents. The stated goals of the treaty include enhancing the efficacy, transparency, and quality of the patent system and preventing patents from being granted erroneously for inventions that are not novel or inventive with regard to genetic resources and traditional knowledge.
Draft Framework for Exercise of March-In Rights under Bayh-Dole Act Targets High Drug Pricing
The National Institute of Standards and Technology (NIST) released for public comment a “Draft Interagency Guidance Framework for Considering the Exercise of March In-Rights” (“March-In Framework”) on December 8, 2023 following the White House’s announcement of initiatives to lower health care and prescription drug costs via competition.
The Federal Trade Commission Put Brand Drug Manufacturers on Notice About Improperly Listing Patents in the Orange Book and Then Followed Through With More Than 100 Patent Challenges
The Federal Trade Commission (FTC) issued a policy statement on September 14, 2023, stating that “[b]rand drug manufacturers may be harming generic competition through the improper listing of patents in the Food and Drug Administration’s (“FDA”) Approved Drug Products with Therapeutic Equivalence Evaluations, known as the ‘Orange Book.’” The FTC’s stated goal was to notify market participants of the FTC’s intent to scrutinize improper Orange Book listings to determine whether they constitute unfair methods of competition in violation of Section 5 of the Federal Trade Commission Act. On November 7, 2023, the FTC followed through on its warning by sending notice letters to more than 10 companies challenging the Orange Book listing of more than 100 patents covering products including specific asthma and other inhaler devices, Restasis multidose bottles, and epinephrine autoinjectors.
Teva v. GSK: The “Skinny” Label Case Pending Before the Supreme Court
On March 29, 2023, the Solicitor General of the United States asked the Supreme Court to review a Federal Circuit judgment in a Hatch-Waxman case between Teva and GSK. In its decision below, the Federal Circuit held that Teva could be held liable for inducement based on language in its “skinny label” and reinstated a $235 million jury award to GSK that the district court had set aside. The question at the heart of the case—as framed by Teva—is: “If a generic drug’s FDA-approved label carves out all of the language that the brand manufacturer has identified as covering its patented uses, can the generic manufacturer be held liable on a theory that its label still intentionally encourages infringement of those carved-out uses?”
